FDAnews
www.fdanews.com/articles/81487-alert-issued-for-sanofi-aventis-menactra

ALERT ISSUED FOR SANOFI-AVENTIS' MENACTRA

October 7, 2005

The FDA and the Centers for Disease Control and Prevention have issued a health alert after five people who received sanofi-aventis' meningitis vaccine Menactra developed a serious nerve disorder.

Five patients, 17 to 18 years old, developed Guillane Barre Syndrome (GBS) two to four weeks after receiving the vaccine, the agencies said recently. GBS causes increasing weakness in the arms and legs and can require hospitalization.

"It is not known yet whether these cases were caused by the vaccine or are coincidental," the FDA and CDC said in a release.

Sanofi-aventis noted in a statement that "no casual relationship has been established between Menactra vaccination and GBS, and there remain several possible explanations for the reported cases of GBS." Premarket studies conducted by sanofi-aventis of more than 7,000 recipients of Menactra showed no GBS cases.

The scare isn't expected to have too much of an impact on sanofi-aventis, a CM-CIC analyst reportedly said, citing the fact that thousands of patients screened before the drug hit the market showed no signs of the disease